Hidden bacteria in artery plaques may predict Post-Surgery risks
NCT ID NCT06935279
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study examined 200 adults who had surgery to remove plaque from their carotid arteries. Researchers identified bacteria living inside the plaques and tracked whether certain types were linked to later strokes, re-narrowing of the artery, or death. The goal was to learn which bacteria might be risky, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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200 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study is a prospective, multicentre, cohort study. This registry study is expected to be conducted mainly at the Advanced Stroke Centre of Neurosurgery, Tang Du Hospital, with another 8-10 national advanced stroke centres participating in the study, with a study population of patients aged 18-80 years undergoing CEA surgery. Patients who met all the inclusion criteria and did not fulfil any of the exclusion criteria could be considered for enrolment after indicating their informed consent to participate in this registry study and their willingness to sign an informed consent form. All patients participating in this study underwent a comprehensive standardised assessment conducted by a multidisciplinary team. The assessment included examination of neurology, neuropsychology and psychiatry, endocrine disorders, and haematological indices. Species identification of bacteria by bacterial 16SrDNA sequence sequencing will be performed and further verified by TEM, live bacterial staining
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1\. Patients clinically diagnosed with moderate-to-severe carotid artery stenosis 2. Age 18 ≤ age ≤ 90 3. Patients undergoing carotid endarterectomy (CEA) 4. Preoperative mRS score of 0-2 5. Preoperative NIHSS score: 0-20 6. Patient's Glasgow Coma Scale (GCS) score upon admission: 8-15 points 7. No fever or evidence of infection at admission 8. Informed consent signed by the subject or their legal representative 9. Good compliance with follow-up visits Exclusion Criteria 1. Brain tumor (presence of mass effect) 2. Patient Glasgow Coma Scale (GCS) score \< 8 3. Refractory hypertension unresponsive to medication (defined as sustained systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) 4. History of severe infection within the past three months 5. Severe or acute heart failure 6. Acute myocardial infarction or severe arrhythmia 7. Undergone major organ surgery or biopsy within the past month 8. Any active bleeding or recent bleeding (gastrointestinal, urinary tract, etc.) within the past month 9. Currently undergoing hemodialysis or peritoneal dialysis; known severe renal impairment (glomerular filtration rate \< 220 mmol/L (2.5 mg/dL)) 10. Concurrent malignant tumors, severe cardiopulmonary disease, or other conditions rendering the patient unable to tolerate surgery 11. Has participated in other interventional clinical studies that may influence the outcome assessment. 12. Severe liver function abnormalities. 13. Other circumstances deemed by the investigator to make participation in this study inappropriate or pose significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric, cognitive, or emotional disorders) 14. Currently receiving immunosuppressive agents or undergoing immunotherapy 15. Severe chest or abdominal trauma requiring surgery 16. Severe Traumatic Brain Injury 17. Infectious Diseases such as Syphilis, AIDS, Hepatitis, and Tuberculosis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Tangdu Hospital
Xian, Shanxi, 710000, China
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Other studies related to the condition(s) this trial covers.
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